DIMENSION®

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) AND REPORTED THEY OBTAINED TWO ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED TWO (2) ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM SYSTEM. THE INITIAL ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION EXL WITH LM SYSTEM AND OBTAINED LOWER RESULTS WHICH WERE CONSIDERED ERRONEOUS. THE SAME SAMPLE WAS REPROCESSED AGAIN ON AN ALTERNATE DIMENSION EXL WITH LM SYSTEM. HIGHER REPROCESSED RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (12-SEP-2024): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE INSTRUMENT DATA FILES AND THE INFORMATION PROVIDED BY THE CUSTOMER. QUALITY CONTROL (QC) RECOVERY WERE WITHIN THE CUSTOMER¿S EXPECTED RANGES. THE REVIEW OF CLOT CHECK DATA INDICATED THE PRESENCE OF MICRO CLOTS IN THE PATIENT SAMPLE RUN ON THE ORIGINAL SYSTEM. THE ISSUE WAS RESOLVED WITH ROUTINE TROUBLESHOOTING. THE CAUSE OF THE EVENT IS CONSISTENT WITH THE PRESENCE OF MICRO CLOTS. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE SIEMENS INVESTIGATION. INITIAL MDR 2517506-2024-00221 WAS FILED ON 29-AUG-2024.